An interventional study of Peer support to promote uptake and persistence of medication assisted treatment (MAT) and Behavioral Activation Treatment (BAT) to reduce depression in HIV Viremia, sponsored by University of Texas, El Paso. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by University of Texas, El Paso · Not applicable, Interventional, and Supportive care
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression.
The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.
Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants complete a survey assessment at baseline, complete their assigned intervention components, and then return to complete follow-up assessment surveys at 3-, 6-,9-, and 12-months. The primary outcome is sustained viral suppression defined as viral load test results of \<400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of the interventions. The secondary aims are to test mediators to explain component 1-2 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's planned enrollment of 220 is above the median of 87 across 45 interventional studies indexed under Viremia.
Browse Viremia studies →University of Texas, El Paso is the lead sponsor of 21 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
meet one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1) Peer-Support for Medication-Assisted Treatment
Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT)
2) Behavioral Activation Therapy
Behavioral: Behavioral Activation Treatment (BAT) to reduce depression
Participants assigned to a combination of: 1. Peer-Support for Medication-Assisted Treatment 2. Behavioral Activation Therap
Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT) · Behavioral: Behavioral Activation Treatment (BAT) to reduce depression
Participants not assigned to any of the 2 components. They are placed on a wait list and will receive components after the primary data collection period.
Behavioral: No Intervention Components
Participants will be assigned to receive peer support to promote uptake of MAT and persistence. This component will consist of two informational sessions, a tailored recovery plan, and on-going support from a peer for the first 6 months.
Participants will be assigned to receive BAT treatment for depression. This component will consist of 8 sessions where participants will identify short and long-term goals, values, and the activities unrelated to substance use that were previously enjoyed or are likely to increase a feeling of well-being. This intervention component focuses on making a plan to troubleshoot barriers to re-engage in these activities. Sessions are delivered weekly. The content includes psycho-education about what depression is, the intervention rationale, and the activities and monitoring of activities, building social contracts to engage networks, and discussion of potential barriers to following through with activities.
Participants not assigned to components 1 and 2
Achievement of Viral Suppression
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of achieved viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Time frame: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment
Viral Suppression at 9-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Time frame: Viral load below or above 400 copiers per mL at the 9-month follow-up assessment
Viral Suppression at 12-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL.
Time frame: Viral load below or above 400 copiers per mL at the 12-month follow-up assessment
Drug use
Will be measured through urine analysis and participants will self-report the frequency (yes vs no), quantity (how much typically consumed when using), and duration of use (how may days in the last 30 days did the participant use and how many times did the participant use yesterday) of various drugs in last 30 days.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Methadone uptake and persistence
Information about date of first dose, current dosage, and number of days on Methadone will be extracted from the medical record.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Drug use frequency and severity of withdrawal and cravings
Opioid Withdrawal Scale - This is a clinician administered scale that assesses the extent opiate withdrawal symptoms based on 11 symptoms (resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose, GI upset, tremors, yawning, anxiety or irritability, gooseflesh skin.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Clinician-assisted rating)
The Montgomery-Asberg Depression Rating Scale will be used, which is a 10-item scale and is clinician-assisted. interview participants and clinicians will rate their level of depression. Symptoms assessed include: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Self-report)
The validated nine-item patient health questionnaire will be administered to participants to measure their level of depression. Participants will be asked to rate how many days of the last 2 weeks they have been bothered by having little interest or pleasure doing things, feeling down, feeling tired, having poor appetite, feeling bad about themselves, having trouble concentrating, moving or speaking slowly, and having thought of hurting themselves.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Behavioral activation for depression
The validated 25 item questionnaire will be administered to participants to assess changes in the behaviors in the past week that underlie their depression such as staying in bed too long, inability to do things that needed to be done, and being active and accomplishing goals.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Adherence to antiretroviral medication (ART)
Percent adherent to ART measure will be extracted from medical records
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Non-adherence to antiretroviral medication (ART)
Non-adherence will be measured as 4-day treatment interruptions (yes vs no) extracted from medical records.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Information, motivation, and behavioral skills to adhere to ART
Participants will answer the validated 30-item scale to assess psychological precursors of adherence including information (e.g., knowledge of how current HIV medications should be taken); Motivation (e.g., support from close significant others to take HIV medication); Behavioral skills (e.g, how easy it is to get HIV medications refills on time)
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Self-efficacy to adhere to ART
Participants will answer the validate 12-items scale assessing perceived self-efficacy to adhere to antiretroviral medication in the last 30 days. The scale asks about the level of confidence the participant has in keeping up with the treatment plan in spite of difficulties such as sided-effects and amid change in sleep and dietary habits and ability to integrate taking medications into the daily routine
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Retention in HIV care
Retention will be assessed by extracting from the medical record: appointments missed and appointments kept. A ratio will be computed using these two measures. At least one appointment kept in each three-month period will be an index of appointment constancy.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Logistical barriers to HIV care
Participants will be asked to indicate whether they have experienced common barriers to HIV care (yes/no) including availability of transportation, being able to access care, clinic hours of operation.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Perceived engagement in HIV care
Participants will answer the 10-item validated scale assessing perceived engagement in HIV care including level of trust in provider, feeling respected and understood by provider, degree of comfort in asking questions and interacting with provider, participant's perceived role in his medical care,.
Time frame: 3-,6-,9-, and 12-month follow-up assessments
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We will share a final modified quantitative dataset with the corresponding code book to validate all findings. The dataset will be modified to remove any potential identifiable information (such as date of birth). Interested parties will be asked to sign an agreement with MPIs Lechuga and Sauceda that specifies that the use of the data is for research purposes only. Furthermore, in order to have the data shared, each party must have: a) adequate systems in place to secure, encrypt and protect the data file to prevent the disclosure of identities, and b) a plan for destruction or returning the data files after all analyses have been completed. Prior to the sharing of data, approval from the requester's Institutional Review Board is required.
Time frame: The data will be made available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
Access criteria: Directions for requesting the dataset will be available at the official study website, which is to be developed. This information will be found in all publications and conference abstract presentations. An individual participant data statement noting steps to access the data is to be developed.
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University of Texas, El Paso